Elixir Pharma is founded in Sep 2009 by a group of seasoned, experienced techno commercial professionals in Ahmadabad, Gujarat (India). Elixir Pharma aspires to emerge as a leading Fine Chemicals, Intermediates, APIs & Chemistry Services provider to Global Life Science Companies so as to enable them in bringing innovative products to markets in the most effective & efficient manner in terms of cost, quality & time. With experienced team of scientists & engineers; GLP compliant labs and WHO GMP manufacturing plants in Ahmadabad, Elixir Pharma is suitably placed to quickly supply quality products APIs and Intermediates across the scale and solve our clients challenging development, scale-up & regulatory needs by offering a broad range of development services.
Date and Time:
6th September – 15th September , 9.30 AM – 2.30 PM
164/A,Naroda GIDC , Phase 2,Near Reliance petrol pump, Ahmedabad
Contact – Rishikesh ( 9712378637 )
5 – 10 years
Not Disclosed
Job description
Role & responsibilities
To review and approve all specifications, STPs, SOPs, BMR, BCR, MFR. –
To review and approve all procedures impacting the quality of raw materials, intermediates or APIs. –
To review and approve of all validation protocols and reports
To assist the Management in executing all GMP / GLP related activities.
– Timely reply to customer queries.
– To monitor and prepare budgetary provisions for procuring new QA equipment, upgrade the facility and smooth working of the department.
– To co-ordinate with Head of manufacturing, Stores, Production and maintenance to document any change control requirement for any changes carried out.
– To release or reject all raw materials, intermediates, packing materials, labeling materials and finished products.
– Site Master File Updation, Validation Master Plan Updation, Quality Manual Updation.
– Handling of Market Complaints, Returns /Recall, Deviations, OOS, Validation report review.
– Vendor on site audits, Handling and Managing of audits to meet AMRI ILS requirement.
– Performing on site audits of vendors as per the requirements given by other AMRI global sites.
– To approve completed batch production and laboratory control records of critical process steps before release of the finished products for distribution.
To ensure quality related complaints are investigated and resolved in coordination with QC, QA, and production departments.
– To handle critical quality systems like deviations, change control, CAPA, training, OOS, validations and Qualifications.
– To review and approve annual product quality reviews.
– Involvement in investigations and closure of CAPA..
– Responsible for releasing or rejecting all API- s, Releasing or rejecting saleable intermediates.
– To appraise the management of any new regulatory requirement and to take appropriate action to implement such changes.
– To review and approve changes that potentially impact intermediate or final product quality.
– To carryout self-inspection (internal audits) of the facility to ensure GMP systems are being adhered to.
– To coordinate with the regulatory and customers auditors for timely completion of auditing, compliance reports etc.
– To review and approve of contract laboratories, critical starting materials vendors, intermediate or APIs contract manufacturers and Quality Agreements Management.
– To make sure that there is a stability data to support retest or expiry dates and storage conditions on final product and or intermediates where appropriate.
– To provide the all documentation support to meet the local and international regulatory requirements.
– Ensure timely dispatches of the material as per the plan and DO requirement.
– To Review and approve Certificate of Analysis as per the customer requirement.
– Taking the GMP rounds to ensure the adherence to GMP requirement.
– To Review and approve Vendor Qualification documents.
– PR requisition in oracle.
– Taking the GMP trainings to build awareness on the site.
To ensure the Compliant Development of Chemical Entities, Key starting Materials, Intermediates, API and their technology transfers to the manufacturing organization.
- Reviewing deviation/Change controls / CAPA and associated investigation reports prior to Technology Transfer
Preferred candidate profile
Perks and benefitsRole:
Quality ConsultantIndustry Type:
Pharmaceutical & Life SciencesDepartment:
Quality AssuranceEmployment Type:
Full Time, PermanentRole Category:
Quality Assurance – Other
Education:
B.Pharma in Any Specialization
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